Interstitial Lung Diseases Cohort Study in China | NCT04370158

Studies
Interstitial Lung Diseases Cohort Study in China

NCT04370158

Sponsor

China-Japan Friendship Hospital

Status

Unknown status

Last Update Posted

Apr 30, 2020Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Interstitial Lung Diseases

Interventions

disease history

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2016Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Apr 29, 2020

First Submission Date that Met QC Criteria

Apr 29, 2020

First Posted Date

Apr 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2020

Last Update Posted Date

Apr 30, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dai Huaping, Deputy Director of Center for Respiratory Diseases, China-Japan Friendship HospitalPrincipal Investigator

Lead Sponsor

China-Japan Friendship HospitalOTHER

Collaborators

Name	Class
The First Affiliated Hospital of Guangzhou Medical University	OTHER
Xiangya Hospital of Central South University	OTHER
First Hospital of China Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this project, the clinical diagnosis of interstitial lung diseases was carried out for the population with suspected interstitial lung diseases selected from the community cohort, and the confirmed patients were included into the existing clinical cohort of interstitial lung diseases, forming an interstitial lung diseases special disease cohort consisting of 3,000 patients and corresponding matched control groups. According to characteristics of interstitial lung disease and the needs of National Key R&D Program of China, this study will formulate unified clinical follow-up strategy to do long-term standardized clinical follow-up in patients with interstitial lung disease. The detailed information for clinical diagnosis and treatment as well as biological samples were collected to identify disease phenotype and build the database and biological sample library for interstitial lung disease cohort study. This study aims to provide evidence for molecular classification, screening and validation of biomarkers as well as precise diagnosis and prevention in patients with interstitial lung disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
disease history	Other	Clinical progression and prognosis of patients with interstitial lung diseases

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Database and biological sample library for Chinese patients with interstitial lung disease	Data analyses will be mainly descriptive.	up to 4 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Physician diagnosed IPF during the last 3 months based upon ATS/ERS/JRS/ALAT guidelines 2011
Agree to sign the informed consent

Exclusion Criteria:

Lung transplantation expected within the next 6 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients from the hospitals involved in this study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Huaping Dai	Recruiting	Beijing	Beijing Municipality	100029	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41673669	Derived	Meng W, Geng J, Chen X, Dai H. Serum CA125 is independently associated with adverse outcomes in primary Sjogren's syndrome-associated interstitial lung disease: a prospective multicenter cohort study. Respir Res. 2026 Feb 12;27(1):150. doi: 10.1186/s12931-026-03573-x.
40967367	Derived	Wang H, Liu A, Ni Y, Wang J, Du J, Xi L, Qiang Y, Xie B, Ren Y, Wang S, Geng J, Deng Y, Huang S, Zhang R, Liu M, Dai H; China Interstitial Lung Disease Collaboration Network. Developing and Validation of a Multimodal-Based Machine Learning Model for Diagnosis of Usual Interstitial Pneumonia: A Prospective Multicenter Study. Chest. 2026 Feb;169(2):415-427. doi: 10.1016/j.chest.2025.08.034. Epub 2025 Sep 16.

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases